(171 days)
Not Found
No
The summary describes a focused ultrasound device for adipose tissue disruption and provides clinical study results. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies.
No
The device is intended for non-invasive reduction in abdominal circumference for aesthetic purposes, not for treating a disease or condition.
No
Explanation: The device description states its purpose is to "disrupt subcutaneous adipose tissue...to provide a non-invasive approach to achieve a desired aesthetic effect" and for "non-invasive reduction in abdominal circumference." This indicates a therapeutic or aesthetic function, not a diagnostic one.
No
The device description explicitly states it is comprised of multiple components, including a control unit and an ultrasonic transducer, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect" and for "non-invasive reduction in abdominal circumference." This describes a therapeutic or aesthetic procedure performed directly on the patient's body.
- Device Description: The device description details a system that uses focused ultrasound to target and disrupt adipose tissue. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the Contour I V3.1 System is a therapeutic/aesthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Contour I V3.1 System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
Product codes
OHV
Device Description
The Contour I is comprised of multiple components, including the control unit and ultrasonic transducer. The Contour I V3.1 selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the Contour I achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal circumference
Indicated Patient Age Range
The study included subjects between age 18 and 65.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
In addition clinical evaluation of the device in the intended population was performed in a multicenter, randomized, controlled study. The study evaluated the safety and effectiveness of the Contour I V3.1 in abdominal circumference reduction relative to no treatment (control) in 150 subjects (safety population) separated into two groups; 118 subjects were included in Group 1 and 32 subjects were included in Group 2. The safety analysis included all subjects for whom a Device or Control procedure was initiated (i.e., after randomization), including subjects from both Group 1 and Group 2. Subjects randomized into Group 1 underwent three study phases-control, treatment, and follow-up. The control phase and device phase results for each Group 1 subject were compared to evaluate the device effect compared to the control phase (no device) in reducing abdominal circumference. Comparatively, subjects randomized to Group 2 underwent two study phases-treatment and follow up (i.e., no control). Group 2 subjects were included in the study to blind the assessor to the subject's treatment group at the time of circumference measurement, and the primary and secondary confirmatory analyses of the study were based on Group 1 data only. To further ensure blinding and to minimize the potential for bias, the individual measuring the subject's abdominal circumference was not the same person who treated the subject, and was blinded to the subject's treatment group.
Group 2 subjects received device treatment for four weeks (device phase) while Group 1 subjects received no treatment for six weeks (control phase) followed by treatment for four weeks; subjects in both groups were measured at the same time points, i.e., evely two weeks. After the first four weeks, Group 2 ended its treatment phase while Group 1 began treatment for four weeks. During Group 1's treatment phase, subjects' abdomen circumferences continued to be measured every 2 weeks in both groups. At the end of Group 1's treatment phase, both groups continued to be measured for an additional 3 months (12 weeks). During these 3 months (12 weeks) of follow up, measurements were performed every 4 weeks in both groups.
The primary effectiveness endpoint measured the difference between the change in circumference for device and control phases of the intent to treat (ITT) primary endpoint population (n=109) relative to the protocol-specified clinically meaningful threshold of -1.5 cm. Two secondary endpoints were also assessed in the study: response rate in comparison to a clinically significant reduction (defined as -1.5 cm), and circumference reduction results achieved in the population of subjects who maintained stable weight during the control phase of the study. The safety endpoint assessed all adverse events and serious adverse events occurring during the study.
The study results for the primary endpoint demonstrated an average circumference reduction of -2.0 cm, which was statistically significant compared to the threshold of -1.5 cm (p=0.0464).
Key Metrics
Average circumference reduction: -2.0 cm
Statistically significant compared to the threshold of -1.5 cm (p=0.0464)
Difference between Control and Device Phases in Circumference Reduction (N=93 ITT population): Mean -2.02 cm, Median -1.7 cm, Lower 95% CL -2.53, Upper 95% CL -1.52, P-Value of Comparison to -1.5 cm 0.0464.
ANCOVA model adjusting for weight change in ITT population: Contour I treatment effect (mean circumference reduction of -1.9 cm) remained statistically significant (p=0.002) and its 95% upper confidence limit was at -1.7 cm, which exceeded the minimum threshold reduction of -1.5 cm.
No device related serious adverse events were reported and most adverse events were non-serious and resolved after no or remedial treatment.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
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K133238 Page 1 of 4
510(k) SUMMARY
Syneron Medical Ltd.'s Contour | System
APR 1 0 2014
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Syneron Medical Ltd. P.O.B. 550 Industrial Zone Tavor Building Yokneam Illit, 20692 Israel
Phone: 972-73-244-2200 Facsimile: 972-73-244-2202
Contact Person: Ruthie Amir, MD, Global Vice President of Clinical Affairs
Date Prepared: April 7, 2014
Name of Device
Syneron Contour I V3.1 System
Common or Usual Name
Focused Ultrasound Stimulator System for Aesthetic Use
Classification
Focused Ultrasound Stimulator System for Aesthetic Use
21 CFR 878.4590, Class II, product code OHV
Predicate Devices
Medicis Technologies Corporation LipoSonix System Model 2 (K112626)
Intended Use / Indications for Use
The Contour I V3.1 System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
Device Description
The Contour I is comprised of multiple components, including the control unit and ultrasonic transducer. The Contour I V3.1 selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the Contour I achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
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Technological Characteristics
The Contour I V3.1 is comprised of the system console, including the computer, and therapeutic ultrasonic transducer delivers the focused ultrasound energy beam to the targeted treatment area, and real-time optical and acoustic feedback on the · treatment is provided via the tracking and guidance system. The transducer functionality is based on the piezoelectric ceramic acoustics core in the transducer.
Performance Data
The following nonclinical performance testing was conducted to support the substantial equivalence of the Contour I to the predicate device, consistent with FDA's "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" (2011). In all instances, the Contour I functioned as intended.
- Biocompatibility testing in accordance with ISO 10993 for skin irritation, sensitization, . cytotoxicity testing supported the biocompatibility of the patient-contacting components of the device.
- . Beam profile testing demonstrated that the acoustic energy is delivered and concentrated in the desired target location, at a focal depth highly similar to that of the predicate device.
- . Acoustic power testing demonstrated that the acoustic power of the transducers is highly predictable with low variability.
- . In vitro acoustic and thermal measurements and computational modeling demonstrated the safety of non-targeted tissues both proximal and distal to the targeted region.
- Software verification and validation was performed, and demonstrated that the . software performs as intended.
- Electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2) and electromagnetic . immunity testing was conducted and demonstrated the electrical safety of the device. Electrical and mechanical safety of the device was evaluated per the related clauses of IEC 60601-2-37.
- In vivo and ex vivo testing in the animal model was performed. In addition, ex vivo . testing on the Contour I family of devices demonstrated the treatment effects of the Contour I, and supported its safety and efficacy profile for the intended use.
In addition clinical evaluation of the device in the intended population was performed in a multicenter, randomized, controlled study. The study evaluated the safety and effectiveness of the Contour I V3.1 in abdominal circumference reduction relative to no treatment (control) in 150 subjects (safety population) separated into two groups; 118 subjects were included in Group 1 and 32 subjects were included in Group 2. The safety analysis included all subjects for whom a Device or Control procedure was initiated (i.e., after randomization), including subjects from both Group 1 and Group 2. Subjects randomized into Group 1 underwent three study phases-control, treatment, and follow-up. The control phase and device phase
2
results for each Group 1 subject were compared to evaluate the device effect compared to the control phase (no device) in reducing abdominal circumference. Comparatively, subjects randomized to Group 2 underwent two study phases-treatment and follow up (i.e., no control). Group 2 subjects were included in the study to blind the assessor to the subject's treatment group at the time of circumference measurement, and the primary and secondary confirmatory analyses of the study were based on Group 1 data only. To further ensure blinding and to minimize the potential for bias, the individual measuring the subject's abdominal circumference was not the same person who treated the subject, and was blinded to the subject's treatment group.
Group 2 subjects received device treatment for four weeks (device phase) while Group 1 subjects received no treatment for six weeks (control phase) followed by treatment for four weeks; subjects in both groups were measured at the same time points, i.e., evely two weeks. After the first four weeks, Group 2 ended its treatment phase while Group 1 began treatment for four weeks. During Group 1's treatment phase, subjects' abdomen circumferences continued to be measured every 2 weeks in both groups. At the end of Group 1's treatment phase, both groups continued to be measured for an additional 3 months (12 weeks). During these 3 months (12 weeks) of follow up, measurements were performed every 4 weeks in both groups.
The study included subjects between age 18 and 65 who met all inclusion criteria and none of the exclusion criteria. The majority of study subjects were Caucasian females of skin types II through IV. Mean age was 44.6 years. Baseline measurements for the study subjects measured 2.7 cm in mean abdominal fat thickness, 95.1 cm in horizontal midline circumference, 69.6 kq in mean weight, and 25.5 kg/m² in average BMI. The primary effectiveness endpoint measured the difference between the change in circumference for device and control phases of the intent to treat (ITT) primary endpoint population (n=109) relative to the protocol-specified clinically meaningful threshold of -1.5 cm. Two secondary endpoints were also assessed in the study: response rate in comparison to a clinically significant reduction (defined as -1.5 cm), and circumference reduction results achieved in the population of subjects who maintained stable weight during the control phase of the study. The safety endpoint assessed all adverse events and serious adverse events occurring during the study.
The study results for the primary endpoint demonstrated an average circumference reduction of -2.0 cm, which was statistically significant compared to the threshold of -1.5 cm (p=0.0464), as shown in the table below.
| Parameter | Mean
(cm) | Median | Lower
95%
CL | Upper
95%
CL | N | P-Value of
Comparison
to -1.5 cm |
|----------------------------------------------------------------------------|--------------|--------|--------------------|--------------------|----|----------------------------------------|
| Change in Circumference in Control
Phase | -0.48 | -0.30 | -0.75 | -0.22 | 93 | |
| Change in Circumference in Device
Phase | -2.51 | -2.0 | -2.94 | -2.09 | 93 | |
| Difference between Control and Device
Phases in Circumference Reduction | -2.02 | -1.7 | -2.53 | -1.52 | 93 | 0.0464 |
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Further, when using analysis of covariance (ANCOVA), results continued to confirm the circumference reduction results observed in the primary endpoint analysis. Based on this model adjusting for weight change in the ITT population, the Contour I treatment effect (mean circumference reduction of -1.9 cm) remained statistically significant (p=0.002) and its 95% upper confidence limit was at -1.7 cm, which exceeded the minimum threshold reduction of -1.5 cm.
Results for the secondary endpoints and sensitivity analyses also supported the circumference reduction effects with Contour I treatment. With all missing data imputed with a zero reduction, the effect of device treatment on circumference reduction remained greater than -1.5 cm. The treatment was administered without anesthetic, and subjects reported a low level of pain. No device related serious adverse events were reported and most adverse events were non-serious and resolved after no or remedial treatment.
Substantial Equivalence
The Contour I has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The technological differences between the Contour I and its predicate device mainly consist of differences in ultrasonic frequencies. However, the devices present comparable energy densities, total energy doses, and focal depths. Further, the additional tracking and guidance feature with the Contour I device is designed to contribute to the overall safety profile of the device. Therefore, the technological differences between the Contour I and its predicate device do not raise any new types of .safety or effectiveness questions. Nonclinical studies of the Contour I have evaluated the performance of the Contour I. Thus, the Contour I is substantially equivalent.
Conclusion
Syneron's Contour I V3.1 System is a Focused Ultrasound Stimulator System for Aesthetic Use Class II device that has been evaluated in nonclinical testing in accordance with FDA's Special Controls Guidance Document. Testing demonstrated that the device performs as intended. The Contour I V3.1 device is substantially equivalent to its predicate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10905 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2014
Syncron Medical Ltd. % Ms. Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K133238
Trade/Device Name: Syneron Contour I V3.1 System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused ultrasound stimulator system for aesthetic use Regulatory Class: Class II Product Code: OHV Dated: March 4, 2014 Received: March 4, 2014
Dear Ms. Hogan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device; subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Janice Hogan
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor YowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
Device Name
Contour 1 v3.1 System
Indications for Use (Describe)
510(k) Number (if known)
The Contour I V3.1 System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive a desired aesthelic effect. It is intended for non-invasive reduction in abdominal circumference
Type of Use (Select one or both, as applicable)
🇿 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
11 Pribliching Sersion 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1-1
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